Posted by Michael Wonder on 06 Mar 2024
Vanda Pharmaceuticals announces FDA update for supplemental NDA for Hetlioz in the treatment of insomnia
6 March 2024 - Vanda Pharmaceuticals today announced that on 4 March 2024, it received a complete response letter from the US FDA as part of its on-going review of Vanda's supplemental new drug application for Hetlioz (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation.
In July 2023, the FDA had assigned a Prescription Drug User Fee Act target date of 4 March 2024 for the completion of its review of the sNDA.
